MAXIBAR Powder for Oral Suspension 98.45%w/w %w/w
国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
产品特点
(SPC)
14-05-2024
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有效成分:
BARIUM SULFATE
可用日期:
Bracco UK Limited
剂量:
98.45%w/w %w/w
药物剂型:
Powder for Oral Suspension
授权日期:
2010-05-28
产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxibar 98.45% w/w powder for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Barium sulfate 98.45% w/w
Also contains sorbitol (E420), 2 g per 340 g dose; and approx. 310 mg sodium per 340 g dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
A white to off-white bulky powder for oral suspension with a slightly sweet fruit taste and some grittiness, intended for
suspension in water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
'Maxibar' is for use as a radiopaque agent during X-ray visualisation of the upper gastro-intestinal tract (oesophagus,
stomach and duodenum). It is designed for optimal use in double contrast X-ray examinations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Maxibar is recommended for oral administration.
The powder must be reconstituted prior to administration (see section 6.6).
The administered dose of Maxibar will depend on the patient in question and the section of the gastrointestinal tract to
be viewed.
ADULTS: Instructions for reconstitution are shown in section 6.6 but the actual administered dose should be determined,
from experience, by the radiologist.
ELDERLY: The dosage should be determined, from experience, by the radiologist. There are no special dosage
recommendations.
CHILDREN: The dosage will be dependent on the size, age, health state and anatomic region to be imaged of the
child. Individual requirements should be determined, from experience, by the radiologist.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/10/2010_
_CRN 2090638_
_page number: 1_
4.3 CONTRAINDICATION
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